U.S. breaks its promise on protecting tobacco control, AGAIN

Published July 19, 2013

U.S. Unlikely To Table Drug IPR, Tobacco Proposal At Current TPP Round

Posted: July 18, 2013

KOTA KINABALU — A spokeswoman for the Office of the U.S. Trade Representative strongly signaled that U.S. negotiators will not offer any new formal proposals here on two controversial issues in the Trans-Pacific Partnership (TPP) talks: the protection of pharmaceutical intellectual property (IP) and a safe harbor from litigation for tobacco regulation.

The USTR spokeswoman said that U.S. negotiators will use the current round to discuss the issue of pharmaceutical IP protection with their counterparts here, but that these discussions would not be based on any new legal text proposals.

The U.S. is also still considering input from stakeholders and members of Congress on a proposal that would protect TPP countries from litigation against regulations that control tobacco for public health reasons, according to the spokeswoman. “No decisions have been made” on tabling text on this issue, the spokeswoman said.

Business sources have said that the tobacco proposal is pushed more by the Department of Health and Human Services than USTR. The proposal has faced strong opposition from members of Congress from tobacco-producing states, as well as agriculture groups who fear that other U.S. trading partners could insist on their own safe harbors for regulations purportedly put in place for health reasons that could potentially hamper U.S. agricultural exports.

The initial U.S. proposal on pharmaceutical IPR would link the extent of protections to the willingness of drug companies to seek quick marketing approval for a product in a TPP country following the drug’s initial approval in another within a specified period of time. Companies that would do so within a yet-to-be specified “access window” would get stronger protections for their intellectual property, including in terms of data exclusivity, than those that did not, according to the proposal.

USTR says the rationale for this proposal is to bring drugs to markets quickly and provide access to medicines. The agency continues to consult with stakeholders and members of Congress on the issue of access to medicines, which is related to pharmaceutical intellectual property issues, according to the USTR spokeswoman.